定量药理学
Pharmacometrics Services
符合法规要求的高质量分析
Pharmacometrics modeling increases our understanding of key factors by leveraging quantitative methods.
Pharmacometrics services use mathematical modeling to quantify interactions between drugs and patients, and it helps optimize drug development and regulatory decisions. Understanding a drug’s benefit-risk profile in a target patient population is key for a successful drug. Pharmacometrics combines various modeling approaches to integrate relevant data that enable the characterization of the efficacy, safety, and biomarker responses of a new drug. The specific applications of pharmacometrics models will evolve during the course of development, and typical questions that they help answer are:
- Selecting doses and dosing regimens for future clinical studies
- Identification of patient factors that impact safety or efficacy
- Optimizing clinical study designs for optimal information content
- Developing, selecting, and optimizing drug formulation
Choose Certara: World’s Largest Pharmacometrics Team
With over 120+ pharmacometricians, the Certara Pharmacometrics team designs and implements MIDD strategies for all types of drug development programs, regardless of therapeutic area, drug modality, and development phase.
优化推进/不推进决策
Certara 提供了高质量的,符合监管要求的药代动力学和药效动力学 (PK/PD) 分析和监管申报文件包的建模。
我们的定量药理学家支持:
- 针对新药审批的临床前和临床研究分析
- 产品延伸
- 许可引进选项
- 产品组合决策
凭借全球最大的 PhD、PharmD 和 MD 顾问团队,我们利用量化方法建立了一个包含药物发现、临床前、早期临床、文献和竞争对手数据的综合知识库,可用于优化决策,包括将促进商业化活动的“推进/不推进”决策。
这些分析还可以为批准后的研究决策提供信息。
量化方法的优势
在过去几年由美国 FDA 批准的所有新药中,有 90% 以上在其开发项目中使用了定量药理学,大多数利用了 Certara 的服务或技术。
- 在药物开发的各个阶段,通过量化框架制定以数据为驱动的决策
- 设计更安全、更有针对性的、更高效的试验
- 第一时间为合适的患者选择合适的剂量
- 最大程度提供商业化取得成功的可能性
建模的好坏取决于您的数据
Want to ensure the highest quality dataset for your analysis? Certara’s data programmers are experts in using SAS to code pharmacokinetic and pharmacodynamic (PK/PD) datasets.
- 我们的数据编程人员为我们的项目创建数据集
- 我们可以创建更高质量的数据集,需要的 QC 周期更少。
- 我们可以减少数据库锁定和执行非房室分析 (NCA)、探索性分析或 PK/PD 建模之间的时间
与专家见面
Rik de Greef
Senior Vice President, Global Lead, Quantitative Science Services
Stephen Duffull
Senior Scientific Advisor, Quantitative Science Services
Matt Zierhut
Vice President, MBMA Capability Lead
JF Marier
Senior Vice President, Canada Region Lead, Quantitative Science Services
Adekemi Taylor
Vice President, QSS-US-1 Region Lead, Quantitative Science Services
Mirjam Trame
Vice President, QSS-US-2 Region Lead, Quantitative Science Services
Amy Cheung
Vice President, Europe/APAC Region Lead, Quantitative Science
Paul Diderichsen
Vice President, Europe/Africa Region Lead, Quantitative Science Services